Fat Burning Standards and Regulations 3

Question 1

Ephedra (ma huang) was banned by the FDA in dietary supplements in 2004 because it posed what risk?

Accepted Answer

Unreasonable risk of cardiovascular events and death

Answer

The FDA banned ephedra-containing supplements after linking them to heart attacks, strokes, and deaths, invoking its authority under DSHEA to act on unreasonable risk.

Question 2

DMAA (1,3-dimethylamylamine) found in some fat burners has been the subject of FDA enforcement actions because it is classified as:

Accepted Answer

An adulterated ingredient not meeting the definition of a dietary ingredient

Answer

The FDA has stated DMAA does not meet the legal definition of a dietary ingredient and has issued warning letters to companies marketing it in supplements.

Question 3

Under DSHEA, a manufacturer must notify the FDA at least how many days before marketing a dietary supplement containing a New Dietary Ingredient (NDI)?

Accepted Answer

75 days

Answer

DSHEA requires a 75-day pre-market notification to the FDA for new dietary ingredients introduced after October 15, 1994.

Question 4

Which of the following statements about Serious Adverse Event Reporting (SAER) for dietary supplements is correct?

Accepted Answer

Manufacturers must report serious adverse events to the FDA within 15 business days

Answer

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) requires manufacturers to submit serious adverse event reports to the FDA within 15 business days.

Question 5

The NSF Certified for Sport® program is primarily valued in fat-burning supplement selection because it ensures:

Accepted Answer

No substances banned by major sports organizations are present

Answer

NSF Certified for Sport® tests for over 270 substances banned by sports organizations, making it critical for athletes who are subject to drug testing.

Fat Burning Practice Test

Fat Burning Practice Test

Fat Burning Standards and Regulations 3